07/11/2019 | Press release | Distributed by Public on 07/11/2019 05:46
Richland WA, July 11, 2019 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCPINK: RDGLD), Dr. Michelle Meyers, IsoPet® certified veterinarian practicing at Vista Veterinary Hospital, treated their first patient, a cat named Drake. The patient has already been released since this is same-day therapy.
Drake's spindle cell sarcoma had been treated previously with external beam therapy but the tumor reoccurred. In this therapy Dr. Meyer focused on treating the margins around the tumor to reduce the chance of re-occurrence. The pet's owner is a veterinarian from Sitka Alaska. He had researched the options and decided that IsoPet was his best choice to extend the life of his cat.
Dr. Mike Korenko stated 'This therapy is the culmination of more than two years of dedicated work to bring Isopet® to market. We will be screening patients for future therapies. The current pricing for Isopet® is competitive with external beam therapy, with the advantage that Y-90 IsoPet® can deliver much higher doses in a single treatment and is precision targeted with insignificant collateral damage to healthy tissue. Over time and as patient volumes increases, we will continue to work to reduce production costs to significantly expand our customer base.' Isopet® provides certified veterinarians with an on-demand next generation cancer therapy alternative without the significant capital expenditure associated with traditional beam therapy. Pet owners who choose Isopet® will know that this important expenditure provides their pet with a powerful new treatment that can dramatically enhance quality of life without the need for the repeated treatment typically required by traditional beam therapy.'
We have created a portal on our web page for interested pet owners to submit their Expression of Interest Application. These will be reviewed by Vista Veterinary Hospital. Any direct callers to Vista will be sent this same application and they will be included in this same screening process.
About Vivos Inc. (OTC: RDGLD)
Vivos Inc. is a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable device, for the treatment of tumors in animals (IsoPet®) and in humans (Radiogel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company's proprietary hydrogel formulation. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.
IsoPet® is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® also has a short half-life - delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to the family.
The IsoPet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on canine soft tissue sarcomas at the University of Missouri is currently underway.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary clinic consortiums.
IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
The Company is also engaging the FDA for premarket clearance to market RadioGel™ for the treatment of advanced basal and squamous cell skin cancers in humans.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words 'may,' 'will,' 'should,' 'plans,' 'expects,' 'anticipates,' 'continue,' 'estimates,' 'projects,' 'intends,' and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
Michael K. Korenko, President & CEO